4 Week Veterans Cannabidiol Intervention

NCT05850754 | Active Not Recruiting

• 1 other identifier: 2302048298
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic agent, and is most supported by the scientific community as an antiepileptic. Additionally, CBD is also associated with claims related to improvements in overall health, pain, anxiety, depression, and sleep; however, the scientific evidence is lacking. The overarching goal of this investigation is to determine the effects of a 4-week CBD intervention on measures of overall health, pain, anxiety, depression, and sleep in a population of US veterans. Primary aims will explore the effects of 4 weeks of CBD on pain, anxiety, and depression. Secondary aims will determine whether 4 weeks of CBD will affect general measures of overall health and sleep.

Conditions

Healthy

Keywords

cannabidiol; veterans; mental health

Outcome Measures

Primary Outcomes (5)

• Change of Veterans RAND 12 Item Health Survey single domains

  Veterans Health Survey RAND (VR-12). Two z scores are reported (Mental Component and Physical Component Scores)patient self-report, 12 questions, minimum value: 12 points, maximum value: 54 points, physical and mental health component summary score compared to a t-score with a mean value of 50 and standard deviation of 10

  Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention

• Change in General Anxiety Disorder Questionnaire Score

  General Anxiety Disorder Questionnaire 7.The GAD-7 scale score ranges from 0 to 21 points. A higher score suggests higher levels of anxiety.

  Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention

• Change in Beck Depression Inventory Score

  Beck Depression Inventory (BDI). Highest score is 63, Lowest score is 0.The higher the score, the more presence of depression.

  Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention

• Change in Defense and Veterans Pain Rating Scale Score

  Defense and Veterans Pain Rating Scale. Each item is scored 0 (no pain) - 10 (pain as bad as it can be). The higher the score indicates higher levels of pain.

  Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention

• Change in Pittsburg Sleep Quality Index Score

  Pittsburg Sleep Quality Index. Scores for each question range from 0-3. Higher scores indicating lower sleep quality.

  Twice, separated by 1 week, prior to the start of the intervention and weekly during the 4 week intervention

Study Arms (2)

CBD Capsule

EXPERIMENTAL

Participants will take capsules containing 50 mg of CBD daily for 4 weeks.

Dietary Supplement: Vantage Hemp CBD

Placebo Capsule

PLACEBO COMPARATOR

Participants will take placebo capsules containing 0 mg of CBD daily for 4 weeks.

Dietary Supplement: Vantage Hemp Placebo Capsule

Interventions

Vantage Hemp CBD DIETARY_SUPPLEMENT

Participants will consume 1 Vantage Hemp capsule, daily for 4 weeks.

CBD Capsule

Vantage Hemp Placebo Capsule DIETARY_SUPPLEMENT

Vantage Hemp Placebo Capsule Intervention

Placebo Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years and older
• Biological Sex: Males or Females, Gender Binary or Non-Binary
• Veteran: US Veterans currently residing in the continental United States

You may not qualify if:

• Secure Internet Access: Ability to use an online platform and agreement to take surveys and communicate with the research team while on a private (not public) device and using a private (not public) connection.
• Pregnancy or Planned Pregnancy: Individuals who are pregnant or who are planning to become pregnant.
• Allergy to Capsule Ingredients: Individuals with a known allergy to porcine gelatin, glycerin, medium chain triglycerides (coconut derived), or CBD.
• Significant Mental Health Challenges: Presence of moderate to severe mental health challenges including paranoia, manic depression, bipolar disorder, severe depression or who are at risk for suicide.
• Significant Health Challenges: Presence of an uncontrolled chronic disease (heart disease, cancer, type 2 diabetes, etc) and/or individuals who are regularly taking anti-seizure drugs, blood thinners, antidepressants, anti-inflammatory drugs, muscle relaxants, sedatives, beta and calcium channel blocker and chemotherapy drugs, HIV antivirals. Individuals with seizure disorders.
• Illegal Substance Use: Individuals who are currently using illegal drugs.
• Cannabis or CBD Use: Individuals who have used a cannabis or CBD product(s) within the last 3 months.
• Residing in a State With CBD Restrictions: Residents of Idaho, Iowa, Missouri, South Dakota, Maine, and Nevada are not able to participate in this study.
• Travel Plans: Plans to travel outside of the continental United States during the 4 week study intervention period.

Sponsors & Collaborators

• University of Northern Colorado: lead

Study Sites (1)

University Of Northern Colorado

Greeley, Colorado, 80639, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Laura Stewart, PhD

  University of Northern Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Study participants will be randomly assigned to 1 of 2 groups and followed throughout a 4 week intervention period.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: May 9, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available when the study is published and will be available for 3 years.
• Access Criteria: Data (without subject ID numbers) will be shared upon email request laura.stewart@unco.edu.

Locations

US (1)